Cleared Special

K041591 - SCORPIO-FLEX POSTERIOR STABILIZED TIBIA...

K041591 is the FDA 510(k) clearance for SCORPIO-FLEX POSTERIOR STABILIZED TIBIA... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Special 510(k) pathway after a 101-day FDA review.

K041591 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
101d
Days
Class 2
Risk

K041591 is an FDA 510(k) clearance for the SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on September 23, 2004 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K041591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2004
Decision Date September 23, 2004
Days to Decision 101 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 778
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K041591.
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT
K042883 · Howmedica Osteonics Corp. · Nov 2004
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES
K042271 · Zimmer, Inc. · Oct 2004
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
K040630 · Implex Corp. · Sep 2004
LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY
K041085 · Depuy, Inc. · Jul 2004
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
K040281 · DePuy Orthopaedics, Inc. · Jul 2004
LPS
K033959 · Depuy, Inc. · Jul 2004